In March 2025, China's National Medical Products Administration (NMPA) released the "Measures for the Implementation of Drug Regulatory Data Protection (Trial, Draft for Comments)," and the "Procedures for Drug Regulatory Data Protection (Draft for Comments)" (collectively, the "Draft Measures"). If enacted, the Draft Measures would operationalize China's long-awaited regulatory data protection (RDP) regime, and reshape the legal and commercial landscape for licensing transactions.

The RDP regime protects non-public clinical trial data and other regulatory data independently generated by an applicant and submitted to NMPA in support of drug approval. During the period during which the data is protected (the "Protection Period"), competing applicants cannot rely on such data when obtaining marketing authorizations or submitting supplemental applications without consent.

Although RDP has existed in principle since 2002, the absence of a framework setting out enforceable procedures has rendered it largely theoretical. The Draft Measures represent the most complete and, more importantly, most actionable framework to date that go well beyond the 2018 draft (that was never finally adopted).

If finalized, the Draft Measures will directly affect deal structuring and economics. For example, RDP may effectively extend exclusivity beyond patent expiry, potentially lengthening royalty tails or delaying generic-triggered price reductions. Second, the drug registration classification, and therefore RDP duration, will depend on the relative timing of overseas and China approvals, thereby making coordinated global development and filing strategies much more of a key deal issue.

Furthermore, achieving protected status (e.g., first generic), will require strict adherence to regulatory timelines. Agreements will need to make clear allocations of responsibility, costs, and consequences if RDP is not obtained. In addition, the Draft Measures do not prohibit consensual third-party use of protected data, raising the possibility – subject to ensuring compliance with data privacy law – of trial data itself becoming a licensable asset.